DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 8/14/2026 have been fully considered but they are not persuasive.
Regarding claim 1: the amendments fail to distinguish over the previously cited art, as Folk discloses that the sensor (20) can be placed within the occlusion to measure pressure before the treatment is determined (Figure 3), wherein this would occur before a stent is delivered (column 4, lines 26-54).
Regarding claim 12, Applicant asserts that Steenwyk and McCaffrey to do disclose the guidewire sensor configuration as claimed. Applicant argues that McCaffrey discloses a single pressure sensor 310 and fails to disclose a guidewire with first and second distal pressure sensors. For clarification, McCaffrey is not relied upon for teaching two sensors on a guidewire, as this is taught by the primary reference Steenwyk. As explained in greater detail below, Steenwyk teaches a device with two sensors placed on a single guidewire, and another embodiment with sensors on nested catheter components. McCaffrey is merely relied upon for teaching that a proximal sensor may be placed on the outer surface of a catheter component. Therefore, the rejection is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 12 first recites “the guidewire includes first and second distal pressure sensors” in lines 3-4. Claim 12 goes on to recite “the first nested catheter integrating a distal sensor” in line 7. The recitation of “pressure data from the distal sensor” in line 12 is unclear, because it is unclear which sensor is being referenced. Due to the use of similar terminology, it is unclear whether the distal sensor at line 12 is referring to the “first and second distal pressure sensors” on the guidewire or the distal sensor on the first nested catheter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3 and 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 10,674,966 (Folk et al.) in view of USPAP 2019/0336135 (Inouye et al.), and further in view of US 9,949,692 (Hunter).
Regarding claim 1: Folk discloses a method for determining a pressure gradient between proximal and distal locations within a vasculature of a patient, the method comprising:
of deploying a stent (50) adjacent to an abnormality cavity (aneurysm “a”)
(see Fig. 8, column 7, line 60 – column 8);
deploying an ancillary device (guide 10) within the vasculature (see step 104), wherein the device comprises a sensor (20),
placing the sensor (20) outside the stent wall and within the abnormality cavity (aneurysm “a”);
measuring pressure with the sensor (20) placed within an aneurysm (a) (see Figure 8; column 8, lines 5-44).
Folk discloses that the sensor (20) can be placed within the occlusion to measure pressure before the treatment is determined (Figure 3), wherein this would occur before a stent is delivered (column 4, lines 26-54). The measurements may aid in determining the type of device and/or length of device to use for treatment (column 5, lines 16-26).
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Folk teaches that additional measurements may be taken upstream or downstream of the abnormality cavity and comparing the measurements to analyze hemodynamics and changes in flow and pressure (column 8, lines 44-60). In another embodiment, Folk discloses a method of determining a pressure gradient by comparing pressure measurements taken upstream and downstream relative to an abnormality (column 5, lines 11-15).
Folk fails to disclose the ancillary device has both a proximal sensor and a distal sensor. Inouye discloses a similar method of determining a pressure gradient in vasculature using proximal and distal pressure data (see description of comparing a first fluid pressure to a second fluid pressure [0075; 0077]).
Inouye teaches the use of an ancillary device having a proximal sensor (30) at the proximal location and a distal sensor (32) at the distal location ([0074; 0087]). The ancillary device enables the operator to take two measurements without repositioning it, wherein one measurement is taken with the distal sensor placed within an abnormality (left atrial appendage 50) and another measurement taken with the proximal sensor that is located proximal to the stent-graft and the abnormality (see proximal sensor 30 outside the cavity 50) (See Fig. 7 below; [0086-0087].
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One of ordinary skill in the art would have found it obvious to substitute the ancillary device having proximal and distal sensors taught by Inouye for the single sensor device of Folk, as the modification allows two measurements to be taken without repositioning the device within vasculature.
Further regarding claim 1: Folk fails to disclose the stent (50) is a stent-graft, but Folk does discuss different types of devices placed within the vasculature such as a flow diverter (col 8, lines 6-9). Hunter teaches that it is advantageous to perform the method of determining a pressure gradient at the site of a stent-graft implanted at the site of an aneurysm in order to detect an endoleak or failure (abstract; col 1, lines 45 – col 2). One of ordinary skill in the art would have found it obvious to perform the modified Folk method with a stent-graft, as taught by Hunter, as the modification merely involves a substitution of one well known type of vascular implant for another that obtains a predictable result of detecting a leak or other failure at the site of an implanted stent graft.
Regarding claim 2: Folk discloses that the ancillary device (10) can be advanced along the outside of the stent to the aneurysm (col 8, lines 39-44). Inouye teaches that the entire ancillary device (34) can be positioned along an outer wall of the stent graft instead of extending through the lumen of the stent graft (10) (see Fig. 7; [0086]).
Regarding claim 3, Folk discloses that measurements are taken with the sensor after deployment of the stent (col 8, lines 22-39). Additionally, Inouye discloses the pressure gradient is calculated after deployment of the stent graft (10) (see description of detection of leakage after deployment of implant 10 [0075-0077]). This meets the requirement of the outputting step performed during a monitoring period relative to a completion of the second deploying step.
Regarding claim 6, Folk discloses a step of measuring pressure after a treatment is completed, using a change in pressure measurements to determine whether a procedure was successful and taking measurements any time during a procedure (column 4, lines 50-60). Therefore, it would have been obvious to repetitively take measurements for a period of time after completion of a repair procedure in order to ensure that the procedure was successful.
Regarding claim 7, Folk discloses a proximal location for a proximal sensor measurement should be outside the aneurysm (see measuring upstream and downstream of the aneurysm at col 7, lines 6-25; col 8, lines 44-55; Fig. 10-11). Additionally, Inouye teaches the proximal location is located outside the abnormality cavity (see proximal sensor 30 outside the cavity 50) (See Fig. 7; [0086-0087]).
Regarding claim 8, Inouye discloses a step of introducing a pressure reducing agent (fluid 36) into the abnormality cavity (50) through a distal end of the ancillary device (34). Inouye describes that there are ideal parameters of fluid flow and pressure if a proper seal is achieved between the implant and the tissue wall [0075-0080]. Although not explicitly stated, it would have been obvious to one of ordinary skill in the art before the time of invention to cease the flow of fluid from the pump if a desired pressure gradient is detected.
Regarding claim 9, since the location of the distal sensor of modified Folk is moveable relative to an outer wall of the stent graft, it would have been further obvious to place the distal sensor closer to the outer wall of the stent graft than the abnormality wall, in order to adjust the location of the sensor for particular application. It is well known that the particular size and shape of aneurysms vary widely, so it is considered obvious to move the distal sensor based on a particular patient’s anatomy.
Regarding claim 10, It is well known that the particular size and shape of aneurysms vary widely, and the size and shape of a particular stent graft used to treat the abnormality would correspondingly vary. Since Inouye teaches proximal sensor (30) is placed proximally of the stent graft (see Fig. 6; [0084-0085]), it would have been further obvious to place the proximal sensor of the modified Folk method proximal to the stent graft in order to obtain desired measurements for a particular patient’s needs.
Regarding claim 11, Folk discloses that the proximal and distal sensor data are compared with one another and/or additional data to perform calculations and determine the state of the aneurysm (column 7, lines 6-36). Inouye also discloses the pressure values are compared, which requires simultaneous use of proximal and distal pressure data [0074-0076]. Therefore, the modified Folk method is considered to render obvious the outputting step includes simultaneous measurement of proximal and distal pressures.
Claim(s) 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over in Folk in view of Inouye and Hunter, as applied to claim 1 above, and further in view of USPAP 2024/0033080 (Steenwyk et al.)
Folk, Inouye and Hunter fail to disclose the proximal and distal sensors placed on separate catheter and guidewire components. Steenwyk teaches that two sensors of an apparatus for measuring pressure gradient in vasculature can be placed on separate components instead of the same component (see wire 110 in Figure 6). An embodiment in Figure 9 discloses an ancillary guidewire (208) integrating a first sensor (216) and an ancillary catheter (202) a second sensor (218), and the ancillary catheter is movable relative to the ancillary guidewire [0070; 0074-0075]. Therefore, the apparatus of Figure 9 can be positioned such that the guidewire (208) includes the proximal sensor and the catheter (202) includes the distal sensor. In light of Steenwyk’s disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the Folk method such that the two sensors are located on separate guidewire and catheter components to allow for their relative positioning.
Steenwyk discloses the proximal and distal arrangement of the sensors can be switched relative to the particular implant being measured (see [0065; 0076]). It would have therefore been obvious to place the proximal sensor on the guidewire and the distal sensor on the catheter, according to the particular location of the vasculature implant being evaluated.
Regarding claim 5, it would have been further obvious to move the catheter relative to the guidewire according to Steenwyk’s teaching [0067] to achieve desired positioning of the sensors.
Claim(s) 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over anticipated by USPAP 2024/0033080 (Steenwyk et al.) in view of USPAP 2020/0046230 (McCaffrey et al.).
Regarding claim 12: Steenwyk discloses a method for determining a pressure gradient between proximal and distal locations within a vasculature of a patient [0081], the method comprising:
deploying a guidewire (504) within the vasculature (see Fig 10);
deploying a first catheter (nosecone shaft 512) over the guidewire (504) within the vasculature, the first nested catheter (512) integrating a distal sensor (508) at the distal location (nosecone 508),
deploying a stent graft (514) within the vasculature to obtain a deployed stent graft;
outputting proximal pressure data from the proximal sensor and indicative of pressure at the proximal location and distal pressure data from the distal sensor and indicative of pressure at the distal location [0068];
and determining the pressure gradient using the proximal and distal pressure data [0050; 0068; 0081].
Although the embodiment of Figure 10 does not include two distal sensors mounted on the guidewire and a second nested catheter, Steenwyk discloses other embodiments with such arrangements. In another embodiment of Figure 6, two distal sensors (104 and 102) are mounted on a single guidewire (see Figure 6; [0057]) Steenwyk further teaches that that the measurement assembly can include a first nested catheter (nosecone 304) having a sensor (302) at its distal end moveably disposed within a second nested catheter (308) that has a sensor (306), wherein the nested catheters are moveably disposed over a guidewire (310) (see Fig. 8; [0067]). Steenwyk teaches that multiple sensors capable of being located at different locations enables a physician to adjust the measurement position as needed to obtain the best measurement possible [0080]. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention to combine sensor arrangements taught by Steenwyk in order to arrive at the claimed configuration of guidewire with two sensors, a first nested catheter with a sensor and a second nested catheter with a sensor, as the modification merely involves a combination of known measurement assemblies that obtains a predictable result of multiple sensors allowing greater versatility in taking measurements for a particular patient’s needs.
While it not explicitly disclosed whether the distal sensor (302) is located on the outer surface of the first nested catheter (312), Steenwyk does teach that is obvious to locate the sensors on a variety of components and that the sensor is exposed to the blood stream to measure pressure [0100]. McCaffrey discloses a known construction of a catheter with a pressure sensor (310), and teaches that it is known the art for a sensor (310) to be located on the outside surface of a catheter body (see description of sensor 310 within an open seat (316) and exposed to fluid through aperture (348) (Fig.9-10; [0054]). Since the McCaffrey device is configured for performing the same function of measuring pressure within vascular blood flow, one of ordinary skill in the art before the effective filing date to configure the distal sensor of the first nested catheter to be on an outer surface, as the modification achieves a predictable result of arranging a pressure sensor on a catheter.
Regarding claim 13, wherein the first nested catheter (304) has an outer diameter less than or equal to an inner diameter of the second nested catheter (308), and the second deploying step including first deploying the first nested catheter and secondly deploying the second nested catheter (see description of positioning the catheters 304 and 308 separately).
Regarding claim 14, wherein a distal end of the second nested catheter (308) is located proximal a distal end portion of the first nested catheter (304) (see Fig. 8).
Regarding claim 15, the distal end portion of the first nested catheter (304) integrates the distal sensor (302) (see Fig. 8; [0068]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
